The objective of the clinical investigation presented is to guarantee the safety and usability of the RESPIRA ADVANCED medical device in patients undergoing mechanical ventilation in the ICU, both stable patients and in the weaning phase. Through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. During the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.
Hospital Universitari Germans Trias y Pujol
Badalona, Barcelona, Spain
Clínica Nostra Senyora del Remei
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes in PaO2 during the ventilation of the patient
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the failure of the device
Amount of patients that required the use of the conventional ventilator due to a therapeutic failure of the investigational device
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device
Evolution of the tidal volume during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device
Evolution of the peak pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device
Evolution of the plateau pressure during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device
Evolution of the breathing rate during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm
Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours
Time frame: This variable will be measured and recorded at 24 hours
Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes of pH during the ventilation of the patient
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes of PaCO2 during the ventilation of the patient
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes of oxygen saturation during the ventilation of the patient
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes of heart rate during the ventilation of the patient
Time frame: This variable will be analyzed at the end of the study (36 hours)
Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation
Significant changes of breathing during the ventilation of the patient
Time frame: This variable will be analyzed at the end of the study (36 hours)
Safety Assessment
Number of device related serious and unexpected adverse events reported during the use of the device
Time frame: This variable will be analyzed at the end of the study (36 hours)
Protective Measures Assessment
Number of alarms activated by the investigational device during the ventilation procedure
Time frame: This variable will be analyzed at the end of the study (36 hours)
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